10 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION
FDA 510(k)
FDA Class 2
·Orthopedic
PIVOX™ Oblique Lateral Spinal System
FDA UDI
MEDTRONIC SOFAMOR DANEK, INC.·00643169606128·SPACER 2133440 OLIF25 27MM 18 DEG 14X40
AGXO
FDA UDI
Oticon A/S·05707131262431·H100, RITE 312 WL CNB AGXO
EVEREST SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
HIGH FIVE
FDA 510(k)
FDA Class 1
·General Hospital
VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER
FDA Adverse Event
Injury
·DIGITAL ANGEL CORPORATION/ JAMM TECHNOLOGIES·Product code NRV·August 5, 2022
TENDRIL SDX
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·October 1, 2014
MECHANICAL (MANUAL) WHEELCHAIR
FDA Adverse Event
Malfunction
·INVAMEX·Product code IOR·May 29, 2013
OCTRODE LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·June 15, 2011
Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare Inc·May 13, 2015